Ambulatory Surgical ProceduresNCT05915624
Tele Nursing Counseling on Anxiety and Patient Satisfaction in Same Day Surgery
A study testing telephone counseiling in people with Ambulatory Surgical Procedures, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
The study was planned to be conducted as a randomized controlled experimental study to examine the effect of preoperative tele-nursing counseling on anxiety and patient satisfaction in same day surgery. The main Research Hypotheses are; Preoperative tele-nursing counseling has no effect on anxiety in same day surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ambulatory Surgical Procedures
- What is being tested?
- telephone counseiling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2022to 30 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Above 18 years old,
- Agreeing to participate in the research,
- Persons who will undergo day surgery in the field of general surgery, urology, orthopedic surgery, plastic surgery, neurosurgery,
- GKS score of 15,
- Not addicted to alcohol
- No psychiatric problems,
Show all 10Show fewer
- Not using antipsychotic, antidepressant and anxiolytic drugs
- According to the ASA (American Society of Anesthesiologists) classification, ASA 1-2-3 -classification
- Speech and hearing impaired
- It is planned to include patients who have an open phone in the study.
Who cannot join
- Preoperative hospitalization
- Patients undergoing emergency surgery
- Patients who want to leave the study at any stage of the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Pre-Surgery Tele Nursing Counseling on Anxiety and Patient Satisfaction in Same Day Surgery
The study was planned to be conducted as a randomized controlled experimental study to examine the effect of preoperative tele-nursing counseling on anxiety and patient satisfaction in same day surgery.
The main Research Hypotheses are; Preoperative tele-nursing counseling has no effect on anxiety in same day surgery.
Preoperative tele-nursing counseling has an effect on anxiety in same day surgery.
Preoperative tele-nursing counseling has no effect on patient satisfaction in same day surgery.
Preoperative tele-nursing counseling has an effect on patient satisfaction in same day surgery.
Read the detailed description
Power analysis was performed using the G*Power (v3.1.7) program to determine the number of samples. The power of the study (α) was accepted as 0.05 (95% confidence level), Type 2 error probability (β) was accepted as 0.20 (80% power level) and the effect size of 0.46 in the relevant literature (Pehlivan, 2021) was taken into account, and the minimum required minimum in the groups was taken into account. It was found that taking the sample size as 74 would be sufficient. In the study, it was aimed to have a total of 148 participants, 74 for the control group and 74 for the experimental group. Considering the possible loss, the study was completed with a total of 160 patients, 80 of which were in the control group and 80 in the experimental group.
While evaluating the findings obtained in the study, SPSS (Statistical Package for the Social Sciences) version 25.0 (IBM Corp., Armonk, NY, USA) program will be used for statistical analysis.
- Conditions
- Ambulatory Surgical Procedures
- Being tested
- telephone counseiling
- Keywords
- ambulatory surgery, anxiety, patient satisfaction
- Medical subject headings
- Anxiety Disorders, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
telephone counseilingOther
One day before the operation, information was given about the operation process via tele-nursing and counseling was provided.
| Study group | Role | What they receive |
|---|---|---|
| telephone counseling group | Experimental | After signing the voluntary informed consent form, the patients in the experimental group were given a Preoperative Patient Information Brochure, prepared by the researcher when they came to the hospital for the surgery date. Data will be collected using the Introductory Information Form and the Surgery-Specific Anxiety Scale, and counseling was provided by tele-nursing information about the surgery process one day before the surgery. Receives: Other: telephone counseiling |
| Control group | No intervention | The patients in the control group were given a Preoperative Patient Information Brochure, which was prepared by the researcher on the day of the surgery, when they came to the hospital for the surgery date after signing the voluntary informed consent form. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgery-Specific Anxiety Scale
It is a 5-point Likert-type scale. (1-Strongly disagree, 2-Disagree, 3-Undecided, 4-Agree, 5-Completely agree). The maximum score to be taken from the scale is 50. In the scale scoring system, the emotions experienced by the patients were collected in 3 different dimensions.
Measured: two hours before going to surgery
Patient's Perception of Nursing Care Scale
It was used to measure the satisfaction level of patients with nursing care. It is required to mark one of the 15 statements that make up the scale: Agree-5, Agree a little-4, Undecided-3, Disagree-2, Strongly Disagree-1 and No response-0. The score given for each item is taken as a basis. Thus, a minimum of 15 and a maximum of 75 points can be obtained from the scale. The cut-off point of the scale is 45. Scores above the cut-off point indicate a positive attitude.
Measured: two hours before discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2023
- Study start1 Sep 2022
- Primary completion30 May 2023
- Study completion30 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ambulatory Surgical ProceduresStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The patients in the experimental group will be given a Preoperative Patient Information Brochure prepared by the researcher when they come to the hospital for the surgery date after the voluntary informed consent form is signed. Data were collected using the Introductory Information Form and the Surgery-Specific Anxiety Scale, and counseling was provided by tele-nursing information about the surgery process one day before the surgery. Patient's Perception of Nursing Care Scale was applied before leaving the hospital after day surgery.The patients in the control group were given a Preoperative Patient Information Brochure, which was prepared by the researcher on the day of the surgery, when they came to the hospital for the surgery date after signing the voluntary informed consent form. Data were collected using the Introductory Information Form and the Surgery-Specific Anxiety Scale. Patient's Perception of Nursing Care Scale was applied before leaving the hospital after day surgery.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Collaborators
- Assoc.Prof.Ezgi Seyhan Ak
- Responsible party
- Principal investigator, Nasır Mehmet Özbek, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05915624
- Sponsor's protocol ID
- IUCESEYHANAK001
- Status last verified
- Jun 2023
- First submitted
- 10 Jun 2023
- Last updated
- 23 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Pre-Surgery Tele Nursing Counseling on Anxiety and Patient Satisfaction in Same Day Surgery
- ClinicalTrials.gov ID
- NCT05915624
- Acronym / sponsor ID
- IUCESEYHANAK001
- Conditions
- Ambulatory Surgical Procedures
- Keywords
- ambulatory surgery, anxiety, patient satisfaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Collaborators
- Assoc.Prof.Ezgi Seyhan Ak
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 30 May 2023 (actual)
- Study completion
- 30 May 2023 (actual)
- First posted
- 23 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study was planned to be conducted as a randomized controlled experimental study to examine the effect of preoperative tele-nursing counseling on anxiety and patient satisfaction in same day surgery.
The main Research Hypotheses are; Preoperative tele-nursing counseling has no effect on anxiety in same day surgery.
Preoperative tele-nursing counseling has an effect on anxiety in same day surgery.
Preoperative tele-nursing counseling has no effect on patient satisfaction in same day surgery.
Preoperative tele-nursing counseling has an effect on patient satisfaction in same day surgery.
Detailed description
Power analysis was performed using the G*Power (v3.1.7) program to determine the number of samples. The power of the study (α) was accepted as 0.05 (95% confidence level), Type 2 error probability (β) was accepted as 0.20 (80% power level) and the effect size of 0.46 in the relevant literature (Pehlivan, 2021) was taken into account, and the minimum required minimum in the groups was taken into account. It was found that taking the sample size as 74 would be sufficient. In the study, it was aimed to have a total of 148 participants, 74 for the control group and 74 for the experimental group. Considering the possible loss, the study was completed with a total of 160 patients, 80 of which were in the control group and 80 in the experimental group.
While evaluating the findings obtained in the study, SPSS (Statistical Package for the Social Sciences) version 25.0 (IBM Corp., Armonk, NY, USA) program will be used for statistical analysis.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The patients in the experimental group will be given a Preoperative Patient Information Brochure prepared by the researcher when they come to the hospital for the surgery date after the voluntary informed consent form is signed. Data were collected using the Introductory Information Form and the Surgery-Specific Anxiety Scale, and counseling was provided by tele-nursing information about the surgery process one day before the surgery. Patient's Perception of Nursing Care Scale was applied before leaving the hospital after day surgery.The patients in the control group were given a Preoperative Patient Information Brochure, which was prepared by the researcher on the day of the surgery, when they came to the hospital for the surgery date after signing the voluntary informed consent form. Data were collected using the Introductory Information Form and the Surgery-Specific Anxiety Scale. Patient's Perception of Nursing Care Scale was applied before leaving the hospital after day surgery.
| Arm | Type | Receives |
|---|---|---|
| telephone counseling group | Experimental | Other: telephone counseilingAfter signing the voluntary informed consent form, the patients in the experimental group were given a Preoperative Patient Information Brochure, prepared by the researcher when they came to the hospital for the surgery date. Data will be collected using the Introductory Information Form and the Surgery-Specific Anxiety Scale, and counseling was provided by tele-nursing information about the surgery process one day before the surgery. |
| Control group | No intervention | –The patients in the control group were given a Preoperative Patient Information Brochure, which was prepared by the researcher on the day of the surgery, when they came to the hospital for the surgery date after signing the voluntary informed consent form. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Above 18 years old,
- Agreeing to participate in the research,
- Persons who will undergo day surgery in the field of general surgery, urology, orthopedic surgery, plastic surgery, neurosurgery,
- GKS score of 15,
- Not addicted to alcohol
Key exclusion criteria (3 listed)
- Preoperative hospitalization
- Patients undergoing emergency surgery
- Patients who want to leave the study at any stage of the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| telephone counseilingOne day before the operation, information was given about the operation process via tele-nursing and counseling was provided. | Other | telephone counseling group |
Primary outcome
Surgery-Specific Anxiety Scale
Time frame: two hours before going to surgery
It is a 5-point Likert-type scale. (1-Strongly disagree, 2-Disagree, 3-Undecided, 4-Agree, 5-Completely agree). The maximum score to be taken from the scale is 50. In the scale scoring system, the emotions experienced by the patients were collected in 3 different dimensions.
Patient's Perception of Nursing Care Scale
Time frame: two hours before discharge
It was used to measure the satisfaction level of patients with nursing care. It is required to mark one of the 15 statements that make up the scale: Agree-5, Agree a little-4, Undecided-3, Disagree-2, Strongly Disagree-1 and No response-0. The score given for each item is taken as a basis. Thus, a minimum of 15 and a maximum of 75 points can be obtained from the scale. The cut-off point of the scale is 45. Scores above the cut-off point indicate a positive attitude.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing telephone counseiling in people with Ambulatory Surgical Procedures, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgery-Specific Anxiety Scale (time frame: two hours before going to surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2023.